Therapeutic Innovation & Regulatory Science
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MedDRA Labeling Groupings to Improve Safety Communication in Product Labels
Therapeutic Innovation & Regulatory Science - Tập 57 - Trang 1-6 - 2022
The granularity and structure of the International Council for Harmonisation’s (ICH) Medical Dictionary for Regulatory Activities (MedDRA) are useful for precise coding of adverse events (AEs) for data analysis. In product labeling for healthcare practitioners, however, the granularity of MedDRA Preferred Terms (PTs) can obscure the communication of adverse reactions (ARs). Driven by a focus on pa...... hiện toàn bộ
Evaluation of the Safety Profile of Direct-Acting Antivirals on Patients with Hepatitis C Virus: A Pharmacovigilance Study
Therapeutic Innovation & Regulatory Science - Tập 57 - Trang 997-1007 - 2023
Hepatitis C virus (HCV) is the primary contributor to chronic hepatic diseases. A rapid change in the situation took place with the advent of oral direct-acting antivirals (DAAs). However, a comprehensive review of the adverse event (AE) profile of the DAAs is lacking. This cross-sectional study aimed to analyze the reported Adverse Drug Reactions (ADRs) with DAA treatment using data from VigiBase...... hiện toàn bộ
International Comparison of Qualification Process for Medical Product Development Tools
Therapeutic Innovation & Regulatory Science - - 2024
Qualification of medical product evaluation tools is underway in the United States, Europe, and Japan to reflect the advancements in the basic science of medical products. In Europe and the U.S., Guidance of Guidances (GoG) policies that clarify regulators’processes, tasks, and methods of sponsor involvement are adopted to issue tool guidance. However, in Japan, a non-GoG type policy focusing on s...... hiện toàn bộ
Introduction to the Special Section on Medical Communications: Medical Communications Transformation Within the Emerging Health Care Landscape
Therapeutic Innovation & Regulatory Science - - 2014
ICH Culture: Its Maintenance and Development
Therapeutic Innovation & Regulatory Science - Tập 51 - Trang 9-10 - 2017
The founding industry members (European Federation of Pharmaceutical Industries and Associations [EFPIA], Japanese Pharmaceutical Manufacturers Association [JPMA], and Pharmaceutical Research and Manufacturers of America [PhRMA]) of the International Council for Harmonisation (ICH) have a 25-year track record of the contribution to ICH. Given that further globalization of ICH is expected, we shoul...... hiện toàn bộ
New Drugs Regulatory Program Modernization: Vision, Strategic Objectives, and Impact
Therapeutic Innovation & Regulatory Science - Tập 55 - Trang 440-446 - 2020
In response to a rapid increase in drug development activity during the past two decades, the Food and Drug Administration’s Center for Drug Evaluation and Research launched a multi-year effort in 2017 to modernize the program by which new drug products are regulated, known as the New Drugs Regulatory Program. Following a detailed analysis of FDA activities in new drug development, premarket revie...... hiện toàn bộ
Postmarketing Safety of Biosimilars: Current Status, Challenges, and Opportunities in the Spontaneous Reporting System
Therapeutic Innovation & Regulatory Science - Tập 54 Số 3 - Trang 667-680 - 2020
Evaluation of Assay Sensitivity and the Concentration-Effect Relationship of Moxifloxacin in a QT/QTc Study in Japan
Therapeutic Innovation & Regulatory Science - Tập 48 - Trang 181-189 - 2014
To investigate the potential for a QT/QTc study in Japan, a randomized, single-blind, crossover study was conducted using moxifloxacin in 64 healthy Japanese male volunteers. A 12-lead Holter electrocardiogram was used to test a relatively small population at each of 4 incorporated clinical research units to confirm the assay sensitivity and efficiency. Moxifloxacin (400 mg) significantly prolonge...... hiện toàn bộ
Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company Practice
Therapeutic Innovation & Regulatory Science - Tập 55 - Trang 118-128 - 2020
The certificate of pharmaceutical product (CPP) was implemented to accelerate the availability of new drugs in developing countries by providing evidence of the quality of products and reducing the time to market through reliance on a prior trusted analysis. However, the CPP format, issuing process and use have not been revised since 1997 and there are significant differences among countries in re...... hiện toàn bộ
Reasons for Premature Conclusion of Late Phase Clinical Trials: An Analysis of ClinicalTrials.gov Registered Phase III Trials
Therapeutic Innovation & Regulatory Science - Tập 54 - Trang 232-239 - 2020
Confirmatory phase III trials aim to provide decisive evidence about a medical product’s safety and efficacy. Although these trials are planned and conducted based on accumulated knowledge, they are not without risk or uncertainty. A trial prematurely concluding contributes to great loss in both financial and human research resources. We categorized and evaluated trials concluded prematurely after...... hiện toàn bộ
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